SN EN 60601-2-30 : 2000

INTRODUCTION<br>SECTION ONE - GENERAL<br>1 Scope and object<br>2 Terminology and definitions<br>3 General requirements<br>4 General requirements for tests<br>5 Classification<br>6 Identification, marking and documents<br>SECTION TWO - ENVIRONMENTAL CONDITIONS<br>SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS<br>14 Requirements related to classification<br>17 Separation<br>19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY <br>&nbsp;&nbsp;&nbsp;CURRENTS<br>20 Dielectric strength<br>SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS<br>21 Mechanical strength<br>22 Moving parts<br>SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EXCESSIVE RADIATION<br>36 ELECTROMAGNETIC COMPATIBILITY<br>SECTION SIX - PROTECTION AGAINST THE HAZARDS OF IGNITION OF <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;FLAMMABLE ANAESTHETIC MIXTURES<br>SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;OTHER SAFETY HAZARDS<br>42 Excessive temperatures<br>44 Overflow, spillage, leakage, humidity, ingress of <br>&nbsp;&nbsp;&nbsp;liquids, cleaning, sterilization and disinfection, and <br>&nbsp;&nbsp;&nbsp;compatibility<br>45 Pressure vessels and parts subject to PRESSURES OUTPUTS<br>49 Interruption of the power supply<br>SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;AGAINST HAZARDOUS OUTPUT<br>50 Accuracy of operating data<br>51 Protection against hazardous output<br>SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS: <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ENVIRONMENTAL TESTS<br>SECTION TEN - CONSTRUCTIONAL REQUIREMENTS<br>56 Components and general assembly<br>57 MAINS PARTS, components and lay-out<br>Annex L (normative) References - Publications mentioned in <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;this standard<br>Annex AA (informative) General guidance and rationale<br>Annex BB (informative) Alarm diagrams<br>Annex ZA (normative) Normative references to international <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;publications with their corresponding <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European publications<br>Annex ZB (informative) Other international publications <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;mentioned in this standard with the <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;references of the relevant European <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;publications<br>Figure 101 - Test for protection against defibrillator <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;discharge<br>Figure 102 - Safety means, SINGLE FAULT CONDITION, adult <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(neonatal) determination<br>Figure 103 - Safety means, SINGLE FAULT CONDITION, adult <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(neonatal) determination<br>Figure 104 - Maximum inflation time, NORMAL CONDITION and <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SINGLE FAULT CONDITION, adult (neonatal) <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;determination<br>Figure 105 - LONG TERM AUTOMATIC MODE NORMAL CONDITION, adult<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(neonatal) determination<br>Figure 106 - LONG TERM AUTOMATIC MODE SINGLE FAULT CONDITION,<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;adult (neonatal) determination <br>Figure 107 - SHORT TERM AUTOMATIC MODE, adult (neonatal) <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;determination<br>Figure 108 - Test layout<br>Figure 109 - ESU test layout<br>Figure 110 - Patient simulator

Specifies criteria for safety and essential performance of AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT, (referred to as equipment). The equipment may be attended or unattended. Does not apply to blood pressure measuring equipment which uses finger transducers or to semi-automatic blood pressure measuring equipment, where each determination typically needs to be initiated manually.